# K172452: Bruxor

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Specialties, LLC
- Decided: Jan 11, 2018 after 150 days
- Product code: OBR (Mouthguard, Over-The-Counter)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K053580 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091660: Custom Comfort Nightguard Version 2, Den Tek Oral Care, Inc. (2009) Summary page 4.

## Indications for use
Bruxor™ is intended to protect teeth and reduce the damage caused by bruxing, or night time teeth grinding, and to prevent the noise associated with bruxing and grinding.

Source page: https://510kreport.com/device/K172452
Methodology: https://510kreport.com/methodology